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PARP Inhibitor

Pembrolizumab + Olaparib for Breast Cancer

Phase 2

Recruiting

Led By Yuan Yuan, MD

Research Sponsored by Yuan Yuan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have ECOG 0 or 1

Have documented BRCA deleterious germline or somatic mutation and/or HDR-defect

Must not have

Is receiving systemic steroid therapy within three days prior to the first dose of pembrolizumab or receiving any other form of immunosuppressive medication

Is expected to require any other form of systemic or localized antineoplastic therapy while on trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the use of immunotherapy and PARP inhibition to treat advanced breast cancer associated with a germline BRCA mutation or HDR-defect.

Who is the study for?

This trial is for adults with advanced breast cancer that's linked to a BRCA mutation or HDR-defect. Participants must have measurable disease, adequate organ function, and a life expectancy of at least 16 weeks. Women should be postmenopausal or use two forms of contraception; men must use condoms. Exclusions include recent other treatments, additional cancers needing treatment, inability to take oral meds, certain infections like HIV/Hepatitis B/C, active autoimmune diseases, and known allergies to the drugs tested.

What is being tested?

The study tests pembrolizumab (an immunotherapy drug) combined with olaparib (a PARP inhibitor) in patients with incurable advanced breast cancer due to BRCA mutations or HDR defects. The main goal is to see how well this combination works by measuring the overall response rate according to specific criteria.

What are the potential side effects?

Possible side effects may include immune-related reactions affecting organs, infusion-related symptoms during administration of pembrolizumab, nausea from olaparib intake along with potential blood cell count changes leading to anemia or infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have a confirmed BRCA mutation or HDR defect.

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My breast cancer has a BRCA mutation or HDR defect and is getting worse despite treatment.

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I have a tumor that can be measured and hasn't been treated with radiation.

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I am postmenopausal or cannot have children and agree to use two effective birth control methods.

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I have a preserved tumor sample available for testing.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on steroids or immunosuppressants as of three days ago.

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I will not need any cancer treatment other than the trial.

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I have another cancer that is getting worse or needs treatment.

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I have a history of HIV or active Hepatitis B/C.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have received an organ or tissue transplant from another person.

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I have cancer that has spread to my brain or spinal cord.

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I have a lung condition not caused by an infection.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I cannot take pills by mouth and have stomach issues affecting medication absorption.

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I have not received a live vaccine in the last 30 days.

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I have not had chemotherapy, targeted therapy, or radiation in the last 3 weeks.

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I have lasting side effects from cancer treatment, but not hair loss.

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I have active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR) per RECIST1.1

Secondary study objectives

Clinical Benefit Rate (CBR = CR+PR+SD) per RECIST 1.1

Duration of Response (DOR) for Complete Response (CR) and Partial Response (PR) per RECIST 1.1

Overall survival (OS)

+1 more

Other study objectives

Exploratory: CBR based on immune-related (ir)RECIST

Exploratory: DOR based on immune-related (ir)RECIST

Exploratory: ORR based on immune-related (ir)RECIST

+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + OlaparibExperimental Treatment2 Interventions

This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Olaparib

2007

Completed Phase 4

~2190